CORE-007: BIOSTATISTICS SHARED RESOURCE (BSR) PROJECT SUMMARY / ABSTRACT The Biostatistics Shared Resource (BSR) provides The Ohio State University Comprehensive Cancer Center (OSUCCC) investigators with a centralized resource for biostatistical expertise. The BSR is directed by Dr. Soledad Fernandez and the Associate Director is Dr. Kevin Coombes (TT). Statistical issues are addressed at all levels of investigation, from the design of experiments to the maintenance of data quality, and from conclusions based on formal hypothesis testing to important leads discovered by data exploration. In support of this objective, the Specific Aims of this resource are to: 1) collaborate with OSUCCC investigators in all aspects of biomedical research: design, implementation and discovery; 2) enable strong and consistent collaborations by providing a biostatistical ?navigator? to all OSUCCC programs and disease groups; and 3) provide biostatistical and methodological review of all cancer protocols submitted to the Clinical Scientific Review Committee (CSRC) and the Data Safety Monitoring Committee (DSMC), and to provide support to the Biospecimen Services Shared Resource and its Total Cancer Care protocol. Over the past five years, the BSR has increased its integration and collaborations with all OSUCCC programs. The main highlights of BSR activities during the last funding period include: 1) BSR biostatisticians supported 254 cancer-related papers and 14 of these had a journal impact factor >10. These metrics represent a 33% increase in number of publications since our last grant. 2) BSR members received support from 11 renewed and 3 new programmatic grants, including the first NCI-funded Thyroid Cancer SPORE and also 36 R01s. 3) BSR hired nine additional biostatisticians to support OSUCCC investigators, including Dr. Kevin Coombes (TT), former Director of the Bioinformatics Shared Resource at MD Anderson Cancer Center. Other recruits have enhanced our clinical trials expertise with Bayesian methodologies. 4) BSR implemented a new biostatistical navigator model to expand, improve and unify support to OSUCCC investigators while maintaining access to the wide breadth of expertise with other biostatisticians across different OSU colleges. 5) The BSR increased its interactions with the Disease Specific Research Groups DSRGs by assigning a dedicated biostatistician to each group. 6) BSR integrates support with other shared resources, such as Biomedical Informatics Shared Resource, Genomics Shared Resource, Pharmacoanalytical Shared Resource, Analytical Cytometry Shared Resource and Behavioral Measurement Shared Resource. 7) BSR members provided education and promoted the benefits of innovative designs for early phase clinical trials to OSUCCC investigators. The BSR leverages extensive institutional support, and seeks only 7.7% support from CCSG funds. The Biostatistics Shared Resource is part of the Quantitative Grouping.